Introduction

As the regulator for pharmacists, pharmacy technicians and pharmacy premises in Great Britain (the Pharmaceutical Society of Northern Ireland is the regulatory and professional representative body for pharmacists in Northern Ireland) it is our job to protect, promote and maintain the health, safety and wellbeing of members of the public, and in particular those members of the public who use or need the services of pharmacy professionals or the services provided at a registered pharmacy.

In developing the proposals set out in this consultation document we have relied heavily on ideas and approaches developed by others. These include the five principles of good regulation first set out by the Better Regulation Executive, as well as the principles for inspection and enforcement proposed by Sir Philip Hampton and the Council for Healthcare Regulatory Excellence’s document, Right-touch Regulation

Endorsing these principles is the simple part; the challenge for us is to demonstrate through our approach to regulation that what we propose is fair and proportionate – that is, in line with the level of risk posed to health, safety and wellbeing – and not over-burdensome. It is also about recognising that sometimes mistakes happen in healthcare which regulation either cannot prevent, or can only do so by taking steps so disproportionate that patients would actually be disadvantaged by, for example, reduced or limited access to services.

In a good regulatory system it is clear to patients and the public who is responsible for upholding standards and other requirements, including relevant law, and that different parts of the regulatory system work together. We are working closely with registrants and professional bodies to identify any areas of regulatory overlap; and with other regulatory bodies and organisations to reduce or eliminate overlap and identify any regulatory gaps.

The public protection triangle

 

Medicines and medical devices themselves need to be safe and effective. The Medicines and Healthcare products Regulatory Agency has the regulatory responsibility here as represented in the first corner of the public protection triangle.

Two other key components are:

  • Competent caring professionals practising to the right standards
  • A safe and effective system for managing and delivering services.

We, the GPhC, have regulatory responsibilities in these two areas. Both are essential. On the basis of quality assured education, training and “fitness to practise” we license people to work as competent caring pharmacy professionals. There are equivalent health professional regulators, such as the General Medical Council and the General Dental Council for doctors and dentists respectively. And secondly, we regulate pharmacies required to register with us. This consultation is about new standards we propose to set for this third important corner of the public protection triangle.

It is important that those responsible for running pharmacy services from the registered pharmacies we regulate know what standards they have to meet. This is in order to ensure there is a safe system for managing and delivering services. And, crucially, the standards need to be set in a way that enables the competent caring professionals on our pharmacy register to practise, as professionals, to the standards we have set for them.

The proposals on which we are consulting take account of all aspects of what is a complex legal framework around medicines and pharmacy, including the legal responsibilities of the “Responsible Pharmacist” defined
in the Medicines Act, and Government regulations made under it. This consultation is about a different subject, including the standards we expect the owners and superintendents of registered pharmacies to meet.

In setting the standards that all registered pharmacies must meet it is important that we do not give pharmacy owners and managers a one-size-fits-all blueprint for safe and effective service delivery. This is because:

  • what works in one pharmacy may not be as effective in another, because of perfectly legitimate differences
  • a regulator like the GPhC cannot and should not take on the responsibilities that rightly sit with owners and managers
  • pharmacy is changing quickly and it would not benefit the public if our rules got in the way of safe and responsible innovation
  • a one-size-fits-all blueprint would impose restrictions and burdens which might be inadequate in one setting but not nearly stringent enough in another, very different setting.

We recognise that our proposed standards are different from the more detailed standards that pharmacy is used to. The new approach will put more onus on pharmacy owners and superintendent pharmacists to consider and manage the risks in their own pharmacies while setting a
clear framework in which they must do so.

It is not enough for us to publish standards for registered pharmacies alone. We must be clear about which premises we believe must be registered with us and must adhere to our standards. We know that patients and the public can get their medicines from other service providers, for example at their doctor’s surgery or while as an inpatient in hospital. We do not have powers to regulate the supply of medicines in these and certain other environments. However we will continue to work with the organisations that do regulate these, as patients and the public would expect the standards to be consistent regardless of who regulates the healthcare setting. And we will set out the approach we plan to take to
securing compliance with the standards and how we will manage non-compliance, including use of our enforcement powers.

This consultation document brings together these three key elements: the registration requirements; the standards; and our approach to compliance and enforcement. We also explain how our approach to regulating the services from registered pharmacies, often referred to as a ‘system regulation’, links to our regulation of individual pharmacists and pharmacy
technicians.

 

 

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